Note: yukon medical was originally made aware of this reported problem on (b)(6) 2016.The initial information provided to yukon indicated that a user or patient may have been impacted (see details below).Additional correspondence was then provided to yukon medical retracting any impact to a user or patient; therefore, the incident was not reported.At a later date (17may2017), yukon medical was contacted by the competent authority to submit as mir for the reported complaint.An initial (b)(4) was submitted to the competent authority on 17may2017.Yukon was unaware at the time that all eu events were required to be reported to the fda.As a result of an fda inspection completed at our site on 6apr2018, it was communicated by the investigator that eu events need to also be reported in the us if the device is marketed in the us regardless of where the reportable incident occurred.Therefore, yukon medical is reporting the event at this time.This is number two of two events that is being reported.Summary of event of product problem: when capping the drug vial with protector viashield (this was later specified as a vialok device by the user), the plastic spike tip folded, making it impossible to extract the drug from the vial.Details regarding user or patient impact: the initial problem report (b)(4) provided by bd/carefusion customer advocacy indicated a patient had an allergic reaction, however in a follow-up correspondence received from the end-user on the issue it was specified that no drug got on the user or patient.No user or patient harm occurred.No drug was involved because the vial access device spike bent (folded) when capping the vial (attaching the adapter to the vial).
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